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RECRUITING
NCT07141030
PHASE1

Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function

Sponsor: Gan & Lee Pharmaceuticals.

View on ClinicalTrials.gov

Summary

This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal renal function and those with mild, moderate or severe renal impairment. The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).

Official title: To Assess the Pharmacokinetic (PK) Differences of GZR18 Injection Between Subjects With Renal Impairment and Those With Normal Renal Function, Providing a Basis for Establishing a Clinical Dosing Regimen for Patients With Renal Impairment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-04-11

Completion Date

2026-03-31

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

GZR18 injection

GZR18 injection:3mg

Locations (1)

Gan & Lee Pharmaceuticals

Beijing, China